A comparative study of the sodium valproate tablets available in the Iranian market with respect to their physic-chemical properties

Abstract

Introduction: The present thesis is kind of the post marketing quality control studies that evaluated the physicochemical properties of sodium valproate tablet dosage forms available in the Iranian pharmaceutical market. Sodium valproate is an anti-epileptic medicine that its anticonvulsant effect has been attributed to the reduction of PIP3, blockage of voltage-gated sodium channels and increase in brain levels of GABA. Aim: The objective of the current study is to evaluate quality of domestic and imported brands of tablet dosage forms of sodium valproate with respect to the BP Pharmacopeia. Materials and methods: Four different brands of valproate sodium tablets were selected and their physicochemical properties were evaluated in terms of assay, uniformity of dosage units, dissolution, disintegration, hardness, friability and variation of weight according to the sodium valproate monograph in BP

Results: The variations of the average weight of all the studied brands were less than 5% and acceptable. All the brands showed acceptable uniformity of dosage units, the disintegration time of all the products was acceptable and they all passed the friability test successfully with friability of less than 1%. In the case of assay, the amount of active ingredient was acceptable in all the studied products except for product A , in the case of dissolution study, except for products C and D that released more than 5% of sodium valproate in the presence of HCl 0.1 N, the others passed the test and finally the hardness of all the products were at the range of 8.1-10.3 Kg and around the highest acceptable level of the recommended range (4-8 Kg). Conclusion: By taking all the findings into the consideration, it can be claimed that the only product which passed all the tests successfully was brand B. However, in the case of other three products, it seems necessary to reconsider their formulation and quality.